Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by London Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01289691
First received: February 1, 2011
Last updated: February 2, 2011
Last verified: February 2011

February 1, 2011
February 2, 2011
July 2010
June 2011   (final data collection date for primary outcome measure)
The incidence of postoperative atelectasis [ Time Frame: Immediately after the surgery - up to 2 days post operative. ] [ Designated as safety issue: No ]
The primary objective is to determine if the incidence of postoperative atelectasis is decreased in the non-surgical lung, during one-lung ventilation (OLV) with mixture of air and oxygen compared to (OLV) using only oxygen (which is our control measurement) .
Same as current
Complete list of historical versions of study NCT01289691 on ClinicalTrials.gov Archive Site
The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) . [ Time Frame: Intra-operative and Post operative day 1 and 2 . ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis.

Patients scheduled for lung lobe resection using video assisted thoracic surgery will be randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.

The primary purpose of this study is to determine if the incidence of postoperative collapse (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to using only oxygen (which is our control measurement) during one-lung ventilation.

One of the concerns with all thoracic procedures employing One Lung Ventilation (OLV) is intra-operative hypoxia due to the large shunt that develops when only one lung is being ventilated. Ventilation with a higher fraction of inspired oxygen (FIO2) is one of the commonly chosen strategies for the treatment of hypoxemia during (OLV) for thoracic surgery. Using an FIO2 of 1.0 at all times during (OLV), however, may increase the risk of absorption atelectasis intra and postoperatively which itself leads to persistent hypoxia and potentially pneumonia.

The aim of this study is therefore to determine the impact of adding air to the inspired fraction of oxygen during (OLV) primarily on the incidence of postoperative atelectasis of the nonsurgical lung after lung resection using video assisted thoracic surgery and secondarily on intraoperative and postoperative oxygenation.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Pulmonary Atelectasis
  • Other: One Lung Ventilation
    Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
    Other Name: OLV
  • Other: One Lung Ventilation
    Patients in this group will be ventilated with only oxygen during one lung ventilation.
    Other Name: OLV
  • Experimental: Air/Oxygen Mixture
    Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
    Intervention: Other: One Lung Ventilation
  • Active Comparator: Oxygen
    Patients in this group will be ventilated with only oxygen during one lung ventilation.
    Intervention: Other: One Lung Ventilation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Competent to give consent to enroll in study
  • Booked for open thoracotomy procedure for lobectomy
  • American Society of Anesthesiologists comorbidity score 1-4

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Pregnant women
  • Inability to insert an arterial line
  • Severe COPD (FEV1 < .7% predicted, or FEV1/FVC < 0.70)
  • Presence of other significant pulmonary impairment (PaO2 on room air 50 mmHg, PaCO2 > 50 mmHg or known pulmonary HTN mean PAP > 25 mmHg)
  • Presence of significant cardiovascular disease (+MIBI that is non-revascularized, CCS ≥ 3 angina, NYHA ≥ 3 CHF, EF (by angiography or echocardiogram < 40%)
  • Chronic renal failure (serum Cr > 200)
  • Altered liver function
Both
18 Years and older
No
Contact: Neal Badner, MD, FRCP(C) +1 (519) 685-8500 ext 55115 Neal.Badner@lhsc.on.ca
Contact: Hesham Youssef, M.B.,B.Ch +1 (519) 685-8500 ext 17820 heshanm.youssef@lhsc.on.ca
Canada
 
NCT01289691
LHSC2010AAPL
No
Neal Badner, London Health Sciences Centre
London Health Sciences Centre
Not Provided
Principal Investigator: Neal Badner, MD, FRCP(C) London Health Science Centre, University Of Western Ontario
London Health Sciences Centre
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP